JP5080384B2 - Packaged medical adhesive composite - Google Patents

Description

  The present invention relates to a combination of a package and a medical adhesive composite such as dressing. The invention also relates to a method of manufacturing the combination and a method of using the combination.

  Articles coated with pressure sensitive adhesives find wide application in the medical and surgical product areas. Examples of medical adhesive composites include dressings, trauma medical materials, covering fabrics, electrodes and the like. These articles are generally packaged so as not to be contaminated and may remain sterilized until the medical adhesive composite is placed in the package. In general, the packaging operation must also take into account sterility after the medical adhesive composite is packaged.

Of the products considered, the medical adhesive composite is a polymer film dressing. These dressings are widely used as a protective layer for wounds because they promote healing in moist environments while acting as a barrier to contaminating liquids and bacteria. Polymer films are also used as surgical coverings due to their barrier properties. Dressings and covering fabrics that conform to the above description are registered trademarks of TEGADERM ^™ (3M Company, St. Paul, Minn.), Registered trademark Bioclous ^™ (Johnson & Johnson Company). ), Brunswick, NJ), registered trademark OP-SITE ^™ (TJ Smith & Nephew, UK, Full) and registered trademark UNIFLEX ^™ (Homedica ( It can be purchased under a number of trade names such as How Media, Lago, Florida).

  The polymer film used in such dressings is compatible, i.e. the film is very thin, flexible, soft and usually transparent. They are generally supplied with a peelable protective liner that covers the adhesive-coated surface of the film. When the liner is peeled, the adhesive-coated films tend to shrink and the films tend to adhere to each other, making the dressing smooth and aseptically difficult to apply to the patient's skin. In order to deal with this problem, various transport methods have been proposed.

  Many delivery methods utilize a carrier frame that prevents film shrinkage prior to application to the patient's skin by providing a harder component. In general, the frame can then be peeled once the dressing is in place. Examples of some frame-carrying thin film dressings include the title of the invention is carrier-carrying dressing and its manufacturing method (CARRIER DELIVERD DRESING AND METHOD OF MANUFACTURE), U.S. Pat. No. 5,531,855; European Patent Publication No. 0 051 935; US Reissue Patent No. 33,727.

  Many such delivery methods include a liner that protects the adhesive of the thin film dressing prior to application to the patient. In use, before peeling the carrier from the dressing, the liner should be peeled to expose the adhesive that attaches the dressing to the patient. Once the dressing is in place for the patient, the carrier is removed. Depending on the user, the carrier may be removed before the liner, which may cause the dressing to fold partially or wholly. As a result, there is a need for an adhesive composite dressing and packaging method that facilitates the application of thin film dressings to patients quickly and uniformly.

  The present invention provides a combination of packaged medical adhesive composites such as dressings. The medical adhesive composite includes a pressure sensitive adhesive attached to a release surface disposed on a bottom sheet of packaging material. Rather than providing the product with a separate release liner, the process of dispensing the medical adhesive composite is simplified by adhering the medical adhesive composite directly to the bottom sheet of packaging material.

  In one aspect, the invention comprises a backing having a top surface and a bottom surface, a pressure sensitive adhesive coated on at least a portion of the bottom surface of the backing, and made from a material that is attached to the backing and is substantially harder than the backing. A medical adhesive composite dressing comprising a carrier that supports the body. The dressing is provided in combination with a package that includes a top sheet disposed on the top surface of the backing, a carrier, and a bottom sheet disposed under the adhesive on the bottom surface of the backing, the composite dressing comprising the top sheet and the bottom surface. Further, the top sheet and the bottom sheet are sealed to each other around the dressing. The bottom sheet includes a release surface that is at least as large as the pressure sensitive adhesive on the bottom surface of the backing, the release surface is attached to the bottom sheet, and the adhesive strength between the release surface and the bottom sheet is the same as the release surface and the bottom surface of the dressing. Stronger than the adhesive strength between adhesives. The release surface may be provided as a coating on the bottom sheet or as a coating on another release liner attached to the bottom sheet.

  The present invention also provides a method for manufacturing a packaged adhesive composite dressing combination comprising providing a backing having a top surface and a bottom surface, and a pressure sensitive adhesive on the bottom surface of the backing; Attaching a carrier supporting the backing to the top surface of the backing; providing a bottom surface of the packaging material; and providing a release surface between the bottom sheet of packaging material and the adhesive on the bottom surface of the backing. Providing a top sheet of packaging material over the composite dressing, wherein the adhesion between the release surface and the bottom sheet is stronger than the adhesion between the release surface and the adhesive, the composite dressing comprising: Placing between the top sheet and the bottom sheet; sealing the top sheet with the bottom sheet around the composite dressing And a step to provide a method for producing a combination product of the packaged adhesive composite dressing. The release surface may be provided as a coating on the bottom sheet or as a coating on another release liner attached to the bottom sheet.

  The present invention provides a method of using a packaged adhesive composite dressing combination comprising providing a packaged dressing combination. The adhesive composite dressing is made of a backing having a top surface and a bottom surface, a pressure sensitive adhesive coated on at least a portion of the bottom surface of the backing, a material that is attached to the backing and is substantially harder than the backing, and supports the backing. Including career. The package containing the composite dressing includes a top sheet disposed on the top surface of the backing and carrier, and a bottom sheet disposed under the adhesive on the bottom surface of the backing, the composite dressing between the top sheet and the bottom sheet. In addition, the top sheet and the bottom sheet are sealed together around the dressing; the release surface is at least as large as the pressure sensitive adhesive, the release surface is attached to the bottom sheet, and the release surface and the bottom sheet The adhesive strength between is greater than the adhesive strength between the release surface and the adhesive on the bottom of the dressing. Once the combination is provided, the method includes separating at least a portion of the top sheet from the bottom sheet to expose the adhesive composite dressing; and separating the adhesive on the bottom surface of the backing from the release surface. Removing the adhesive composite dressing from the bottom sheet of packaging material; and applying the adhesive and attached backing to the patient. The release surface may be provided as a coating on the bottom sheet or as a coating on another release liner attached to the bottom sheet.

  The present invention also provides a packaged medical adhesive composite combination. The medical adhesive composite includes a substrate having a top surface and a bottom surface; and a pressure sensitive adhesive coated on at least a portion of the bottom surface of the substrate. The accompanying package containing the medical adhesive composite is a top sheet disposed on the top surface of the medical adhesive composite substrate; and a bottom sheet disposed under the adhesive of the medical adhesive composite. The medical adhesive composite is disposed between the top sheet and the bottom sheet, and the top sheet and the bottom sheet are sealed together around the medical adhesive composite; and the bottom sheet of the backing; A release surface that is at least as large as the pressure sensitive adhesive and includes a release liner attached to the bottom sheet, wherein the adhesive strength between the release liner and the bottom sheet is the adhesive of the release liner and the medical adhesive composite; Greater than the adhesive strength between.

The present invention also provides a packaged combination of medical adhesive composites. The medical adhesive composite includes a substrate having a top surface and a bottom surface; and a pressure sensitive adhesive attached to at least a portion of the bottom surface of the substrate. A combination package containing a medical adhesive composite includes: a top sheet disposed on a top surface of the substrate of the medical adhesive composite; a bottom sheet disposed below the adhesive of the medical adhesive composite; ; at least a portion the bottom sheet of substantially all of the top of the cold aggregation sealing material upper sheet (cohesive cold seal material, hereinafter referred to as cohesive sealing material), aggregation sealing material of the upper surface sheet agglomerated sealing material facing the bottom sheet, facing, top sheet and the bottom sheet, the cohesive sealing material, are sealed together around the medical adhesive composite, the agglomerated sealing material; medical adhesive at least as large as the pressure sensitive adhesive composite, a release surface comprising a coated release coated on aggregation sealing material on the bottom sheet, and an aggregate sealing material of the release coating and the bottom sheet Chakukyodo is greater than the adhesive strength between the release coating and the adhesive of the medical adhesive composite includes a release surface.

These and other features and advantages of the combination and method according to the present invention are set forth in the detailed description and drawings set forth below.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS FIG. 1 illustrates one example of an adhesive composite product and package combination according to the present invention. The combination of the present invention is useful in combination with any pressure sensitive adhesive coated medical or surgical product that is packaged to prevent contamination and / or maintain sterility of the product after sterilization. As pressure sensitive adhesive coated products used in conjunction with the present invention generally comprise a layer of pressure sensitive adhesive on a backing or other substrate, they are referred to herein as “medical adhesive composites”. Can be called.

  One type of example of a medical adhesive composite useful in combination with this specification includes dressings that generally have a flexible backing with a pressure sensitive adhesive coating disposed on the backing surface, trauma medical materials, and the like. . Exemplary backings include nonwoven fibrous webs, woven fibrous webs, knits, foams, films and other suitable backing materials. The medical adhesive composite may also include other devices including an electrode and a pressure sensitive adhesive layer on the substrate.

Some preferred flexible backing materials for dressings provided in combination with this specification are translucent or transparent polymer films, including flexible elastomeric films. The present invention is particularly useful in the field of medical adhesive composites having a water vapor permeable film backing, commonly used in trauma medical materials, dressings and similar products. Granted US Pat. Nos. 3,645,835 and 4,595,001 describe methods for producing such films and methods for testing their permeability. Preferably, the film / adhesive composite should be permeable to water vapor at a rate equal to or greater than the skin. Preferably, the adhesive coated films, when using a fall cup method as described in U.S. Patent No. 4,595,001, at least 300g / m ^2/24 hr / 37 / C / 100~10% RH , further preferably at least 700g / m ^2/24 hr / 37 / C / 100~10% RH , and most preferably to transmit water vapor at least 2000g / m ^2/24 hr / 37 / C / 100~10% RH speed.

  The film backing used in conjunction with the present invention may be compatible with anatomical surfaces. As such, when a film backing is applied to an anatomical surface, the film backing will conform to the surface as the surface is moved. Preferred film backings are also compatible with anatomical joints. When the joint is bent and then returned to the unbent position, the film backing expands and contracts to fit the joint flex, but is sufficient to remain fit to the joint when the joint is returned to the unbent state. It has elasticity.

  A description of such features of preferred film backings for use with the present invention can be found in granted US Pat. Nos. 5,088,483 and 5,160,315. As discussed, particularly preferred film backings are elastomeric polyurethane, polyester or polyether block amide films or combinations thereof. These films combine the desirable elastic properties found in preferred backings, high water vapor permeability and transparency.

  Pressure sensitive adhesives that can be used in the medical adhesive composites of the present invention are common adhesives applied to the skin such as the acrylate copolymers described in US Reissue Patent No. 24,906, in particular 97: 3 iso-octyl acrylate: acrylamide copolymer. Also preferred are 70:15:15 isooctyl acrylate: ethylene oxide acrylate: acrylic acid terpolymers as described in US Pat. No. 4,737,410 (see Example 31). Other useful adhesives are described in U.S. Pat. Nos. 3,389,827, 4,112,213, 4,310,509 and 4,323,557. It is also contemplated to add drugs or antimicrobial agents to the adhesive as described in US Pat. Nos. 4,310,509 and 4,323,557.

  The preferred pressure sensitive adhesive described above is preferably permeable to water vapor at a rate equal to or greater than that of human skin. Such features can be achieved by selecting a suitable adhesive, but as described in U.S. Pat. No. 4,595,001, such as a pattern that covers the adhesive on the backing, Other methods of achieving a high moisture transmission rate may be used.

  In a preferred embodiment according to the present invention, the selection of adhesives is limited to those that are safe for use on human or animal skin, preferably those of the class known as “hypoallergenic” adhesives. The Preferred acrylate copolymers are this class of adhesives.

  Liners are available from various manufacturers in a wide variety of unique forms. Those skilled in the art typically test liners against selected adhesives in simulated use conditions to arrive at a product with desirable release characteristics.

  The carrier material is preferably substantially harder than the backing so that the backing does not shrink or bend, in whole or in part, during application of the dressing. The carrier material must be able to adhere to the backing by any suitable method such as thermal bonding, adhesives, mechanical bonding, wax coating, surface energy attraction, and the like. The bond is firm but must be peelable, that is, the carrier and backing can be separated without damaging the bond between the backing body or the pressure sensitive adhesive of the backing and the patient's skin. That is, the adhesive strength between the carrier and the backing is less than the adhesive strength between the backing adhesive and the patient's skin. Also, as discussed more fully below, the adhesion between the carrier and the backing is stronger than the adhesion between the adhesive on the bottom of the backing, such as a pressure sensitive adhesive, and the release liner or surface of the package. Must.

  In one preferred embodiment, for the purpose of producing a preferred dressing, the carrier material can be heat bonded to the backing, with or without the low adhesion coating described below. In general, heat-bondable carrier materials include, but are not limited to, polyethylene / vinyl acetate copolymer coated paper and polyester film. An example of a preferred heat bondable carrier material is polyethylene / vinyl acetate copolymer coated super calender kraft paper (1-80BKG-157PE; Daubert Coated Products, Inc., Willowbrook, Ill.). is there.

  The adhesive composite of the present invention is also coated on the top of the backing, preferably as a solution of a blend of polyvinyl N-octadecylcarbamate and silicone resin, as described in US Pat. No. 5,531,855. It may have a low adhesion coating. Preferred low adhesion coatings are compatible with thermal bonding between the carrier and the backing and also maintain low adhesion after deposition. The top surface of the adhesive composite of the present invention preferably has a low adhesion coating, but adhesive composites without such a coating are also considered to be within the scope of the present invention.

  Referring to FIG. 1, one embodiment of a medical adhesive composite dressing 10 is preferably a compatible backing 14 as described above; a low adhesion coating 13 on the top surface of the backing 14; A carrier 17 attached to the top surface of the backing 14; and a pressure sensitive adhesive 16 on the bottom surface of the backing 14. It will be appreciated that a low adhesion coating may be used as needed in the dressing 10.

  In FIG. 1, the window portion cut into the carrier 17 is preferably removed to create a window 15 and expose a portion of the top surface of the backing 14. If the backing 14 is transparent or translucent, the window 15 is useful to assist in placing the dressing 10 on the patient. However, it will be appreciated that in some examples, the carrier 17 may not have the window 15, that is, the carrier 17 may have the same extent as the backing 14.

  In dressings where a window is provided, the removal of the window portion of the carrier material 17 that normally covers the window 15 may be necessary during manufacturing. The removal eliminates one step of the well-known window-type dressing transport process (i.e., removing a portion of the carrier material from the window 15 before removing the dressing 10 from the bottom sheet 22). Reduce waste on the side. However, some consumers prefer that the portion of the carrier 17 that normally covers the window 15 remains completely until the dressing 10 reaches the final consumer. The portion of carrier 17 remaining after window removal preferably forms a frame near the substantial periphery of backing 14 and supports the backing after removal from the package.

  The carrier 17 preferably has at least one tab extending beyond the periphery of the backing 14 to provide a means for peeling the dressing 10 from the bottom sheet 22 of the package without contacting the adhesive 16. 19 The tab 19 is preferably completely integral with the carrier 17 so that the dressing 10 is peeled from the packaging material by pulling the tag from the bottom sheet 22 of the packaging material (described below).

  The carrier 17 is preferably attached to the backing 14 (on the low adhesion coating 13) by thermal bonding. Other bonding mechanisms such as adhesives, mechanical bonding, wax coating, surface energy attraction, etc. may be used instead of the preferred thermal bonding method.

  Regardless of the type of adhesion method used to attach the carrier 17 to the backing 14, the adhesion should be firm but should be peelable, i.e., the carrier 17 and the backing 14 are either the body of the backing 14 or the backing. It can be separated without damaging the bond between the pressure sensitive adhesive 16 and the patient's skin after applying the dressing.

  The dressing 10 is disposed in a package having a top sheet 20 and a bottom sheet 22. The material used for the packaging sheets 20 and 22 may be paper, polyethylene, polypropylene, polyester or a composite of any of these materials. The main requirement of the packaging material is its ability to provide a sealable package and compatibility with the sterilization process. One preferred packaging material for the top sheets 20 and 22 is 25 lb. Rheinlander Medical Kraft Paper (Phoenix Products Company, Milwaukee, Wis.).

The top sheet 20 and the bottom sheet 22 each preferably have layers 21 and 23 of agglomerated sealing material on their respective finished or inner surfaces. Generally, when activated by pressurization or pressurization and warming, the cohesive sealing material forms a bond. An example of a suitable cohesive sealing material is described in US Pat. No. 2,529,060. As a result, the areas of the top sheet 20 and the bottom sheet 22 that are not separated by the dressing 10 are bonded to seal the dressing 10 between the top and bottom sheets 20 and 22 of the package.

One preferred means of adhering the top and bottom sheets 20 and 22 of the packaging material is a cohesive sealing material as described above, but the top and bottom sheets 20 and 22 of the packaging material can be applied by thermal bonding, contact adhesives. It will be understood that each dressing 10 can be sealed around by any other suitable means, including pressure sensitive adhesives, mechanical adhesives, and the like. Regardless of the sealing mechanism, it is preferably compatible with sterilization processes such as gamma irradiation, ethylene oxide and the like.

  One or both of the top sheet 20 and the bottom sheet 22 preferably form tabs 26 and 28 that are not adhered and bonded together along one edge. Tabs 26 and 28 facilitate the separation of top and bottom sheets 20 and 22 and are exposed to release dressing 10 from bottom sheet 22.

  The bottom sheet 22 preferably has a release surface 24 on which the adhesive 16 of the backing 14 is disposed when a combination dressing and package is produced. The release surface 24 should be at least as large as the adhesive 16 of the backing 14, but in some instances, to simplify the attachment and placement of the dressing 10 on the bottom sheet 22 of packaging material, The peeled surface may be larger.

  The release surface 24 may have a release coating on the surface of the bottom sheet 22, or referring to FIG. 1A, the release surface 24 may be provided in the form of another liner 24a coated with a release coating 24b. The liner 24a can then be separately attached to the bottom sheet 22 of packaging material to expose the release surface 24b in order to adhere the adhesive 16 to the dressing 10. Unless otherwise indicated, the term “release surface” is used below to describe either the release coating provided to the bottom sheet 22 or the release agent 24b provided to the liner 24a attached to the bottom sheet 22. The

  In embodiments where the release surface 24 is a release coating applied to the bottom sheet 22, the adhesive used to seal the top and bottom sheets 20 and 22 of the packaging material is applied to the entire surface of the bottom sheet 22. Will be understood. When the adhesive 23 is provided on the entire surface of the bottom sheet 22, the release surface 24 is applied to the adhesive 23 disposed on the bottom sheet 22 with a single layer of release material, for example, 100% solid ultraviolet curable silicone release material. Will be provided by direct coating. Examples of suitable release materials include silicones such as UV-9300 and UV-9315 manufactured by GE Silicones, General Electric Company, Waterford, NY.

  The release material that forms the release surface 24 is preferably coated in an amount sufficient to provide the desired release characteristics that allow for the removal of the backing 13 if desired. In the exemplary release material described above, the coverage is generally about 0.6 grams / square meter or more, more preferably about 0.9 grams / square meter or more. Generally, the release material is coated at about 5 grams / square meter or less, more preferably at about 2.0 grams / square meter or less.

  The release coating 24 may be applied by, for example, offset printing, rotary screen printing, rotogravure processes and any other equivalent method or methods well known to those skilled in the art.

  A release liner 24a suitable for use as the release surface 24 of the combination of the present invention may be made from kraft paper, polyethylene, polypropylene, polyester or any composite of these materials. As discussed above, the release surface 24 preferably includes a release agent such as a fluoro compound or silicone.

For example, US Pat. No. 4,472,480 describes a low surface energy perfluorochemical liner. Some preferred liners are paper, polyolefin film or polyester film coated with a silicone release material. Examples of commercially available silicone-coated release papers include the registered trademark POLYSLIK ^™ silicone release from James River Co., HP Smith Division (Bedford, Ill.). Paper and silicone release paper supplied by Doubt Coated Products, Inc., Willowbrook, Ill.). Some preferred liners are described in the examples below.

Other combinations of adhesive and release agent are contemplated for using embodiments according to the present invention. Those skilled in the art are familiar with how to test a new combination of adhesive and release surface to arrive at a combination with the desired properties in the final product. Considerations directly related to the selection of the silicone release surface can be found in Chapter 18 of the Handbook of Pressure Sensitive Technology , Van Nostrand-Reinhold, 1982, 384-403. Can be found on the page. U.S. Pat. No. 4,472,480 also describes considerations directly related to the selection of perfluoropolyether release liners.

When the release surface 24 is provided on another release liner (as shown in FIG. 1A), the release liner 24a is preferably used to bond the top sheet 20 and the bottom sheet 22 of packaging material. Are attached to the bottom sheet 22 using the same cohesive sealing material . As a result, the release liner 24a has a surface facing the layer 24c of cohesive sealing material on the bottom surface, ie, the bottom sheet 22 of the package (see FIG. 1). The aggregation sealing material layer 24c adheres to the aggregation sealing material layer 23 of the bottom sheet 22 of the package. As a result, the dressing 10 can be fixed at an appropriate position of the bottom sheet at the same time that the top sheet 20 and the bottom sheet 22 are bonded to each other. Alternatively, the release liner 24a is adhered to the bottom sheet 22 by any suitable means including, but not limited to, contact adhesive, pressure sensitive adhesive, mechanical adhesion, thermal adhesion, wax coating, surface energy attraction, etc. Can be done.

  For a system that uses another release liner 24a to provide a release surface 24, one possible advantage is to prevent shrinkage or other deformation of the dressing 10 during placement between the wrapping sheets 20 and 22. Is easier. As noted above, the preferred dressing 10 uses a highly compatible, flexible backing 14 that has a tendency to bend itself. The carrier 17 can be an aid in preventing the backing 14 from shrinking, but by adding a release liner 24 a to the composite dressing 10, it can be further helped in preventing the shrinkage that occurs when the dressing 10 is packaged.

  Regardless of the actual mechanism used to provide the release surface 24 to the bottom sheet 22 of packaging material, the adhesion between the release surface 24 of the packaging material and the bottom sheet 22 is the same as the adhesive 16 of the dressing 10. It should be stronger than the bond between the release surface 24 and it must be ensured that the dressing 10 can always be easily peeled from the bottom sheet 22 of the package. It is that difference in relative bond strength that provides the ease of using the combination of the present invention.

  Regardless of whether the release surface 24 is provided by coating a release material on the adhesive layer 23 of the bottom sheet 22, or whether the release liner 24a is attached to the bottom sheet 22, the present invention provides: By reducing the packaging material specification requirements, significant advantages can be provided. The desired release surface 24 of the appropriate size can be supplied at the same time as the dressing packaging, thus reducing the item specification since only one type of packaging material used for the bottom sheet 22 of the package is required. be able to. This concept is discussed in more detail with reference to FIGS. 8 and 9 below.

  Another embodiment of a dressing 110 for use in a package according to the present invention is illustrated in FIGS. Dressing 110 is an adhesive composite that includes a carrier 117, a backing 114, a pressure sensitive adhesive 116, and a pad 118 attached to the adhesive 116. The backing 114 has a top surface and a bottom surface. Dressing 110 is placed on bottom sheet 122 of the package in a manner similar to that described above for dressing 10.

  The carrier 117 preferably has at least one tab 119 for handling the dressing 110. Like the dressing 10 of FIG. 1, the dressing 110 also has an opening or window 115 that exposes a portion of the top surface of the backing 114. The carrier 117 preferably extends around the entire periphery of the backing 114 and has a depth control die cut 111 to facilitate removal of the carrier 117 from the backing 114 after the dressing 110 has been applied to the patient. Also good.

  FIG. 3 is a bottom view of the dressing 110 illustrating the exposed adhesive layer 116 and pad 118 positioned near the center of the dressing 110. In general, the absorbent pad 118 can be made from a number of materials including, but not limited to, woven or non-woven cotton, rayon, non-woven, hydrocolloid, foam, and combinations thereof. The pad 118 may also contain a number of substances including antibacterial agents, drugs for transdermal drug delivery, chemical indicators for monitoring patient hormones or other substances, combinations thereof, and the like. Further, although pad 118 is shown as being in the center of dressing 110, it may take any suitable shape and / or be located at a location that is not in the center of dressing 110, as desired.

  It should be noted that the removal of the carrier material 117 from the window portion 115 of the dressing 110 is advantageous for dressings that incorporate the pad 118. The pad 118 tends to deform the backing 114 and, if the material is still present when the pad 118 is placed on the dressing 110, with the carrier material 117 that would be placed in the normal window 115. There is a tendency to cause lamination.

  Also, another release liner can be used to provide the desired release cotton 124 for the bottom sheet 122 of the package, while placing the dressing 110 between the top sheet 120 and the bottom sheet 122 of the package. , It can also help to support the backing 114. This advantage may be particularly useful when using dressings where a portion of the backing is not supported by the carrier.

  As shown in FIGS. 1-3, a carrier is provided to support the backing after removal from the package. As used in conjunction with the present invention, the term “support” means that the carrier can maintain the backing in any desired orientation after the user removes the dressing from the bottom sheet of the package, and at the same time Can be prevented from contracting or bending from each other. The carrier preferably supports the entire backing or at least a substantial portion of the periphery by being separably attached to the entire surface of the backing or at least a substantial portion of the periphery. However, it may be sufficient to support the two opposite sides of the backing, as illustrated in FIG. 3A. The carrier 217 has two separate pieces attached to the same backing 214 in opposing arrangements. Each portion of the carrier 217 preferably has a tab 219 that facilitates handling of the dressing 210. After the dressing 210 has been removed from the package (not shown), the backing 214 has an opposing carrier portion 217 to allow the dressing to be applied without shrinking, and then the carrier portion 217 to be removed. In use, the backing 214 can be held in an extended state.

  Adding a pad 218 to the dressing 210 can also help support the backing 214 by supporting the backing 214 separately in the pad 218 region after removing the dressing 210 from the package.

  The carrier portion 217 can be peeled from the backing as described in the dressing above. Alternatively, the dressing 210 may also have another bond between the carrier 217 and the backing 214 where the carrier is securely attached by the backing 214. In that form, the backing 214 is preferably perforated along the end 220 of the carrier portion 217 to facilitate removal of the carrier 217 (and attached backing 214) after the dressing 210 has been applied to the patient. Is provided.

  Although FIGS. 1-3A illustrate dressings useful in the combination according to the present invention, it will be understood that the dressings can take any desired shape. The dressing may also incorporate additional features such as an allergy test window, a receptacle for collecting effluent, and the like.

  4-9, flow charts and schematics illustrating several methods of manufacturing a packaged dressing combination according to the present invention are described. Referring to FIG. 4, step 40 preferably includes providing an adhesive composite made from a backing / backing (pressure sensitive) adhesive / waste liner. Some preferred materials for the backing and backing adhesive are described above. The waste liner preferably comprises any suitable liner having release properties that allow easy release from the backing adhesive, as discussed below.

  Step 42 is disclosed in US Pat. No. 5,531,855 to provide tape-over features and to minimize surface friction between the backing and other objects or surfaces, which also reduces unwanted removal of dressings. Providing a low adhesion coating on the top surface of the backing as described. It will be understood that this step is performed as needed and that a low adhesion coating may or may not be provided.

  The carrier material is die cut 44 to form a window present in the center of the carrier of some dressings provided in the combination according to the invention. The die cutting operation can be performed using a rotary die cutting apparatus that is well known to those skilled in the art. After the windows have been die cut into the carrier material, they are optionally removed at step 46 before the carrier material is attached to the adhesive composite. The window die cut into the carrier material can be removed using a number of methods well known to those skilled in the art. Such methods include the use of a removal vacuum, air pressure, gravity and / or small diameter nip rolls that cause the window to be out of the framed carrier material. Although steps 42, 44 and 46 are illustrated sequentially in FIG. 4, it will be understood that they are performed simultaneously and are illustrated sequentially for convenience only.

  One preferred method includes providing a window in the carrier material, but it will be understood that if the carrier is generally attached to the entire top surface of the backing, the carrier does not have any window.

  After the low adhesion coating 42 used as needed, the die cut step 44 and the window removal step 46 are completed, and the carrier material (with the window removed) may be deposited 48 with a low adhesion coating on the top surface of the backing. If a suitable bond is provided between the carrier and the backing, the bonding step 48 may include thermal bonding, adhesive bonding, mechanical bonding, wax coating, surface energy attraction, and the like. As discussed above, it is desirable for the present invention that the adhesion between the carrier and the backing is stronger than the adhesion between the release surface of the bottom sheet of the package and the adhesive coated on the backing.

  Although window die cut and removal steps 44 and 46 are illustrated as being performed prior to attaching the carrier to the backing of step 48, another preferred method is step 48 prior to die cut and window removal steps 44 and 46. The carrier is attached to the backing. In this method, the carrier is preferably not attached to the backing of the window area used as needed to facilitate removal of the window from the composite dressing. The die cut step 44 also relates to a carrier material depth control die cut operation so that the backing is not cut when the window is cut from the carrier material.

  Once the window has been removed in steps 44 and 46 and the depositing step 48 has been performed, the waste liner used to protect the backing backing adhesive is removed in step 50 to expose the backing adhesive. The remaining composite of carrier / backing / backing adhesive is then passed through the nip station when the pad can be placed on the backing adhesive in step 52. Preferably, the pad is placed in step 52 using a die cut roll that cuts the pad from the web of pad material (described above) to the desired shape and places the pad on the backing adhesive. Other methods of providing pads are well known to those skilled in the art and include, for example, pick and place devices or any other suitable method.

  It will also be appreciated that step 52 is performed as needed, since the dressing can be configured without the use of any pads.

Once the pad is placed in step 52, in step 54, a set of nip rolls is used to laminate the composite dressing comprising the carrier / backing / backing adhesive / pad to the release liner. The release liner preferably includes the cohesive sealing material necessary to attach the release liner to the bottom sheet of the package, as described above. The cohesive sealing material is provided on the side of the release liner opposite the side laminated to the backing adhesive.

The result of step 54 is a laminate comprising carrier / low adhesion coating / backing / backing adhesive / pad / release liner / cohesive sealing material . Both low adhesion coatings and pads are used as needed in the combination and method of making the combination according to the present invention. Moreover, the window formed in the carrier is used as necessary. If present, the carrier material in the window region may be left in place or removed as described above.

The next step of the illustrated method includes converting the adhesive composite web into a dressing and packaging the dressing. The web is preferably moved to a rotary die sheet station, thereby cutting the dressing from the web in step 56 to remove and discard any debris or waste material. The dressing can then be fed to the packaging step 58 where the dressing is laminated between the top and bottom sheets of packaging material. The packaging step preferably uses a packaging material comprising a cohesive sealing material (described above) that adheres to the top and bottom sheets around each dressing. Preferably, the cohesive sealing material of the release surface including another liner is bonded to the cohesive sealing material of the bottom sheet of the packaging material. Alternative mechanisms for attaching the packaging sheets to each other and providing a release surface for the bottom sheet of the package are described above.

  At this stage, a composite comprising the top packaging sheet / carrier / low adhesion coating / backing / backing adhesive / pad / release liner / bottom packaging sheet is fed to a packaging sheet station (preferably a rotary die) and the web is fed into the sheet Step 60 is performed to form individual packages.

  It will be appreciated that there are other ways of performing step 40, i.e., providing the backing / backing (pressure sensitive) adhesive / waste liner composite used in step 40 above. In one alternative method, the backing may be extruded or coated onto a waste carrier to form a backing / waste carrier composite. The backing adhesive may then be coated on the waste liner to form the backing adhesive / liner composite. The backing adhesive / waste liner may then be laminated to the backing / waste carrier composite to form a waste carrier / backing / backing adhesive / waste liner composite. Finally, the waste carrier may be removed from the backing to provide a composite comprising a backing / backing (pressure sensitive) adhesive / waste liner composite that can be processed as described in the method of FIG. .

  In another method of providing a backing / backing (pressure sensitive) adhesive / waste liner composite, the backing adhesive is coated onto the waste liner and the backing material is extruded or coated directly onto the pressure sensitive adhesive to provide a backing / A backing (pressure sensitive) adhesive / liner composite is provided. This second method is somewhat advantageous because it does not use waste carriers that reduce manufacturing and processing costs. However, both these and other methods are contemplated for use in the method according to the present invention.

  FIG. 5 is a block diagram of a more simplified method according to the present invention. The first step involves providing an adhesive dressing composite comprising a carrier / backing / backing adhesive. This composite may be in the form of a continuous web or in the form of individual dressings. The carrier, backing and adhesive may be provided in any suitable combination of materials, as described above. Step 62 includes providing a bottom sheet of packaging material that includes a release surface. The release surface may be a covering of the bottom sheet, or may be disposed on another liner attached to the bottom sheet. Step 64 includes contacting the adhesive side of the composite and the release surface. Step 66 includes sealing the top and bottom sheets of packaging material over the composite. Although one order of the above steps is illustrated in FIG. 5, it will be understood that these steps may be performed in any suitable order. For example, step 62 may be completed by first contacting the release liner with an adhesive and then attaching to the bottom sheet of packaging material to provide a release surface for the bottom sheet of packaging material (see FIG. 4 for the method). See the method described in).

  FIG. 6 illustrates one schematic diagram of a web fed rotary processing apparatus that may be used to produce a dressing and package combination according to the present invention. Details of designing such devices will be well known to those skilled in the art. Commercially available rotary web processing devices useful for performing the method of the present invention, including depth controlled die-cut systems, are, for example, Mark Andy Company (St. Louis, Mo.) and Vernal Rotary Systems (Bernal Rotary Systems). Systems) (Troy, Michigan).

  Turning to FIG. 6, the roll 72 preferably comprises a heat-adhesive carrier material (also indicated at 72), as described above, having a heat-seal side 73 shown as a thread. The second input roll 70 comprises a low adhesion coating / backing / backing (pressure sensitive) adhesive / waste liner composite (also indicated at 70) according to the present invention. It will be appreciated that a low adhesion coating may be used as needed. As shown, the low adhesion coating / backing portion 74 is rolled up and the waste liner 76 is rolled up. The web of the input roll 70 is indicated by a line between the nip 81 formed between the nip roll 80 and the heating roll 82.

  Before the carrier material 72 is thermally bonded to the low adhesion coating / backing / backing (pressure sensitive) adhesive / waste liner composite 70, the die cut roll 86 and the anvil roll 87 die cut the carrier material 72 to provide a carrier material 72. Form a window. The window 88 may be removed using the various means described above. Alternatively, it will be understood that the window may be depth controlled die cut into the carrier material 72 after a thermal bonding operation performed at the nip 81. If the window is removed after thermal bonding, when the web leaves the heated roll nip 81, the heat roll 82 has its peripheral portion to avoid the thermal bonding area of the web corresponding to the finished dressing window. May have a cavity (not shown) disposed on the surface. In yet another method, no window may be provided in the carrier material.

  The carrier / low adhesion coating / backing / backing adhesive / waste liner composite web is then passed over the knife edge 90 where the waste liner 91 is removed from the composite web to expose the backing adhesive. If the backing adhesive is exposed, the pad may be attached to the composite web. The input roll 92 provides pad material (also shown at 92) to the die roll 93 above the anvil roll 94 and cuts the desired pad (not shown) from the pad material. The pad is then placed on the backing adhesive using the nip between the die roll 93 and the backing roll 95. Next, the pad material impurities 92a that are not used are removed and discarded.

  At this point, the composite includes a carrier / low adhesion coating / backing / backing adhesive backing pad (although it will be understood that the low adhesion coating and pad are used as needed). The product web is fed to the nip 96.

The input roll 97 provides a release surface 98 a that faces the backing adhesive on a release liner (also indicated by 97) fed to the nip 96. The opposite side of release liner 97 is preferably coated with a cohesive sealing material 98b that is used to adhere release liner 97 to the bottom sheet of packaging material (as described above). Beyond the nip 96, the composite web 100 now includes carrier / low adhesion coating / backing / backing adhesive / pad / release liner / cohesive sealing material .

The composite web 100 is fed to the sheet forming station 99, where the web 100 is cut into the desired separate dressing (not shown) to remove and discard the miscellaneous material 100a resulting from the sheet forming operation. Preferably, the dressing is quickly supplied to the packaging nip. Input roll 102 supplies a top sheet of packaging material (also indicated by 104) to packaging nip 101, and input roll 104 supplies a bottom sheet of packaging material (also indicated by 104) to station 101. Preferably, the topsheet 102 has a cohesive sealing material 103, when the bottom sheet 104, which is preferably pressure, adhere to each other, aggregation sealing to seal the dressing between the top sheet 102 and bottom sheet 104 Material 105 is included. When the release liner 97 includes a compatible cohesive sealing material 98b, the release liner material on the dressing adheres to the bottom sheet 104.

  At this point, the composite web includes a separate dressing disposed between the top and bottom surfaces of the packaging material. The web 106 is then fed to a sheet forming station 107 (preferably a rotary die) where the wrapped dressing 108 is separated and subjected to further processing such as sterilization.

  FIG. 7 illustrates another schematic diagram of a web-fed rotary processing apparatus that can be used to produce a dressing and package combination according to the present invention. As shown, the production line includes a supply of an adhesive dressing composite web 140 comprising the following components: carrier / backing / adhesive.

  The web 140 contacts the release liner so that the adhesive surface of the web 140 contacts the release surface on the release liner. It is understood that a pad may be placed on the web 140 adhesive prior to contacting the release liner 142 with the composite web 140 adhesive, if desired. One method of providing a pad on the adhesive web surface is described in conjunction with FIG. 6 above. At this point, composite 144 includes at least the following components: carrier / backing / adhesive / release liner.

The release liner 142 is then adhered to the bottom sheet of the packaging material 146. Prior to attaching the release liner 142 to the bottom sheet 146, it is preferred, but not necessary, to separate the dressing from the carrier / backing / adhesive / release liner composite 144, such as a die cut. As discussed above, the release liner 142 is also preferably adhered to the bottom sheet 146 with a stronger bond than the bond between the release liner 142 and the backing adhesive. One method of attaching the release liner 142 to the bottom sheet 146 is to adhere to the side of the release liner 142 opposite the release surface with a cohesive sealing material on the bottom sheet 146 of the packaging material, affecting the desired adhesion. Cover the cohesive sealing material . Other methods of attaching release liner 142 to the bottom sheet of packaging material 146 have been discussed above.

As shown in FIG. 7, the top sheet of packaging material 148 also attaches to the bottom sheet of packaging material 146 at the same station where the release liner 142 attaches to the bottom sheet of packaging material 146. This step is useful when the adhesion between the release liner 142 and the bottom sheet 146 and the adhesion between the top sheet 148 and the bottom sheet 146 are made using, for example, the cohesive sealing material described above. Depending on the actual mechanism used to form such an adhesion, the actual steps of attaching such components may be performed at the same station or at different, i.e. sequential stations. Will be understood. For example, release liner 142 can be bonded to the bottom sheet at one station, and then bottom sheet 148 can be attached to bottom sheet 146 to form a package around each dressing.

Turning now to FIG. 8, another method of manufacturing a packaged medical adhesive composite according to the present invention is described. The method includes providing a roll of top sheet packaging material 202 and a roll of bottom sheet packaging material 212. Preferably, both top and bottom sheet materials 202 and 212 are provided with a cohesive sealing material that allows the two materials 202 and 212 to form a sealed package.

  The top sheet packaging material 202 is advanced through the print station 204 where the figures, product information, etc. are applied to the web and then advanced to the drying or curing station 206 of the printing process that requires drying or curing. The printed web is then advanced to nip station 220.

  The bottom sheet packaging material 212 is advanced through the print station where the adhesive on the top surface of the material 212 is coated with the release material as described above. One example of a suitable release material is a 100% solids UV curable silicone material. Others will be well known to those skilled in the art. After the release surface has been formed on the web 212, it is advanced to a drying or curing station 216, if desired. After completion of the release surface, the web 212 is then advanced to a station 230 where the medical adhesive composite is placed in the release region of the web 212.

  After the medical adhesive composite is placed on the release surface of the bottom sheet packaging material, the web 212 (with the medical adhesive composite) is advanced to the nip station 220 to seal the top and bottom sheets of the package. Thereby forming a seal around each of the medical adhesive composites. At this point, the web 212 having a top sheet and a bottom sheet containing the medical adhesive composite is preferably advanced to the sheet forming station 222 where the packaged product is separated into the desired separate packages.

  Another method of manufacturing a packaged medical adhesive composite according to the present invention is described in combination with FIG. The method includes providing a roll 302 of top sheet packaging material and a roll 312 of bottom sheet packaging material. In the preferred method, it is preferred to use either a contact adhesive or a pressure sensitive adhesive to seal the top and bottom sheets of packaging material. In this method, the top and bottom sheet materials 302 and 312 are preferably provided without any adhesive coating or layers necessary to provide the desired sealed package. Such materials are coated with a line as described below.

  The bottom packaging material web 312 is advanced to the coating station 314 where the release material is printed or otherwise coated on the top surface of the web 312. The release material that is coated or otherwise applied at station 314 forms the release surface of the package as described above. After the release material is applied at station 314, the web 312 can be advanced to a drying or curing station 316 to dry or cure the release material, if necessary.

  From station 316 onward, the web 312 with release material is advanced to station 318 where contact or pressure sensitive adhesive is applied to the top surface of the web 312. In the illustrated method, it may be preferable to print on the adhesive using, for example, a rubber plate printing station, a rotary screen printer, or other suitable process. Regardless of the actual material applied, it is preferred that the adhesive be applied to the web 312 in a pattern that forms or roughly outlines the dressing in which the adhesive is packaged.

  After the adhesive coating station 318, the adhesive coated web 312 is advanced to a drying or curing station 319 where the adhesive coated on the web 312 can be dried or cured at the station 318. After drying or curing, the web 312 is advanced to station 330 where the medical adhesive composite is placed on the release surface formed at stations 314 and 316. After the medical adhesive composite is placed at station 330, web 312 is advanced to nip station 320.

  Looking at the top sheet, the web of packaging material 302 is advanced through the print station 304 where figures, product information, etc. can be applied to the web 302. After printing at station 304, web 302 is advanced to a drying or curing station 306 for printing processes that require drying or curing.

  The printed web 302 is then advanced to a second coating station 308 where contact adhesive can be applied to the underside of the web 302. In the illustrated method, it may be preferable to print on the adhesive coating under the web 302. The contact adhesive can be applied by a rubber plate printing station, a rotary screen printer or other suitable process. The adhesive can be applied to the entire surface of the web 302, but is preferably applied in a pattern that forms a frame or contours of the medical adhesive composite to be packaged.

  After the adhesive coating station 308, the web 302 is advanced to a drying or curing station 310 where the adhesive coated on the web 302 is dried or cured at the station 308. After drying or curing, the web 302 is advanced to the nip station 320.

  The second coating station 308 and the accompanying drying or curing station 310 are used as needed, and the bottom sheet of the packaging material 312 (because of its nature, both surfaces to be joined are coated with contact adhesive. It will be appreciated that if they are coated with a pressure sensitive adhesive so as to face the contact adhesive, they may be removed. However, if the web 312 is coated with a pressure sensitive adhesive, the top sheet of the packaging material 302 only needs to apply force to the pressure sensitive adhesive to form the desired seal.

The schematic diagrams provided in FIGS. 6-9 represent only possible apparatus diagrams and are to be construed as limiting the method of the invention as defined in the claims appended hereto. One skilled in the art will understand that this should not be done. For example, referring to the process illustrated in FIG. 6, it is possible to provide a station for applying a release material to the preferred cohesive sealing material 105 provided on the bottom sheet of packaging material unwound from the roll 104. Let's go. Similarly, a print station may be arranged to print figures, product information, etc. on the top sheet of packaging material unwound from roll 102. In a similar manner, the printing and coating station may be supplied in the process illustrated in FIG.

Generally required to develop “make-in-place” systems and package a variety of different products by integrating processing steps such as printing the top sheet, applying adhesives, release materials, etc. This reduces the inventory of packaging materials. In general, the packaging web must be coated with adhesive or printed with product information in a separate step, thereby creating an item description for such product. In at least some of the more integrated methods described above, the packaging material can be provided simply, i.e. without any adhesive, cohesive sealing material and / or post-printing information. As a result, only basic packaging materials need to be managed in stock, and then unfinished materials can be finished at the same time as the packaging process (and in some cases, products are manufactured as well) (See, for example, FIG. 6).

After producing individually packaged products, they are generally sterilized, especially in the case of dressings, wound cohesive sealing materials and the like. One skilled in the art will understand that sterilization of the resulting product can affect the bond strength. In particular, it is well known that the strength of the adhesive between the preferred backing adhesive and the patient's skin is affected by gamma sterilization. Gamma sterilization has also been found to have some effect in strengthening thermal bonding, but the effect is not as important as the effect on backing adhesive / skin bond strength. Used in conjunction with the present invention to ensure that the final product, i.e. dressing and packaging combination, has the desired relative adhesive strength as discussed above and ensures proper functioning of the product. Such variations must be taken into account when selecting any adhesive, thermal bonding material and release agent.

  One apparatus believed to be useful for performing at least some of the methods according to the present invention is the name of the invention rotary drum converter (ROTARY) by J. Riedel and C. Niven. DRUM CONVERTER), commonly assigned US patent application Ser. No. 08 / 442,823, filed May 17, 1996.

The following non-limiting examples further illustrate the articles and methods of the present invention. All parts and proportions are expressed by weight unless otherwise indicated.
Example 1
Made according to US Pat. No. 4,737,410 (Example 31) comprising a terpolymer of 70% units of isooctyl acrylate, 16% units of ethylene oxide acrylate, and 14% units of acrylic acid. Using a horizontal knife coater, the pressure sensitive adhesive was deposited on one side of a 60 pound double coated release liner (Daubert Coated Products, Inc., Willowbrook, Ill.) 33.5 grams / Applied in square meters.

  A 1.2 mil (30 micrometer) Estane 58309 NAT022 polyurethane resin (manufactured by BF Goodrich, Cleveland, Ohio) is laminated to the adhesive surface to provide a backing for the dressing. Formed. The backing was gravure coated with a low adhesion back coating using a 200 line pyramid knurled roll and dried. The solutions used were 1) a silicone resin blend of 95% units SS4300 and 5% units SR-0545, both manufactured by General Electric (Waterford, NY), and 90% ( 2) containing 5% solids of polyvinyl N-octadecylcarbamate in xylene-toluene (22% by weight, 78% by weight), US Pat. No. 2,532,011 A 6% solids solution (20 parts silicone and 80 parts polyvinyl N-octadecylcarbamate) containing a backsizing solution based on

  The resulting low adhesion coating / backing / adhesive / liner composite was cut to the desired width. A carrier material (1-80 BKG-157 & PE, manufactured by Dauber Coated Products, Inc.) was die cut to form a window, which was then removed. The polyethylene (PE) side of the carrier material was then heat laminated to a backing over the low adhesion coating by the method taught in US Pat. No. 5,531,855.

The liner (Daubert 2-60BKG-157-99AM) was then removed and replaced with a product liner having a release agent coating surface and a cohesive sealing material coating surface. The product liner is a cohesive sealing material coating agent prepared by Phoenix Stock # PHX-3006 on one side with a coverage of 2.4-4.0 grams / square meter (1.5-2.5 pounds / 3000 feet). Made from coated 25 # Rineiander medical kraft paper (Phoenix Products Company, Milwaukee, Wis.). The other side of the product liner was coated with a UV curable silicone coating, commercially available from Douglas-Hanson Company, Hammond, Wisconsin, at a coverage of 1.5-2.5 grams / square meter.

A composite product consisting of carrier / low-adhesion coating / backing / backing adhesive / product liner is spread out as a dressing using a rotary die-cutting device and made into a cold seal package by Phoenix Products Company. I stored it. The packaging includes two layers, one coated with an anchor coating from Stock Products PHX-3023 from Phoenix Products Company, and the other from Stock Products # PHX-300 from Phoenix Products Company. Transfer coating is applied. The cold seal side of the adhesive covering the product liner was immediately bonded to the package without additional processing steps. Subsequently, the finished agglomerated sealing material for trauma was radiation sterilized to confirm its function. The packaging skin opened normally, the wound cohesive sealing material was easily peeled off from the adhesive cover, and the adhesive cover was attached to the packaging material. Using a frame carrier, the product could be taken out of the package with the adhesive surface exposed and ready to be applied to the skin.

Example 2
8 inch x 10 inch (0.20 meter x 0.25 meter) of a single side coated silicone release liner identified as Akurosil BL 19 MGH SILOXC3R / 0 commercially available from International Paper Company, Menasha, Wisconsin. ) Was applied with a cohesive sealing material prepared by Phoenix Stock # PHX-3006 from Phoenix Products Company. Using the double-coated product release liner / cold seal thus obtained, only the release liner / cold seal paper described above was replaced to make a sample similar to that described in Example 1. The result was the same as that of Example 1. These samples were not irradiated.

Example 3
8 inch x 10 inch (0.20 meter x 0.25 meter) sample of a single side coated silicone release liner identified as ESP-43 reference number 48889 from LohjanPaperi Oy, Lohia, Finland The agglomerated sealing material prepared by Phoenix Products # PHX-3006 from Phoenix Products Company was applied. Using the double coated product release liner / cold seal thus obtained, only the release liner / cold seal paper described above was replaced to make a sample similar to that described in Example 1. The result was the same as that of Example 1. These samples were not irradiated.

Example 4
A 6 inch x 36 inch (0.15 meter x 0.91 meter) sample of a single side coated silicone release liner, identified as ESP-48, manufactured by LohjanPaperi Oy, Lohia, Finland. An agglomerated sealing material prepared by diluting a Sanford Rubber Element from Sanford Corporation of Bellwood, Calif. To 50% by weight with heptane was applied. Using the double coated product release liner / cold seal thus obtained, only the release liner / cold seal paper described above was replaced to make a sample similar to that described in Example 1. The result was the same as that of Example 1. These samples were not irradiated.

Example 5
The sample of packaging material of Example 1 (4 inches × 10 yards / 0.1 meter × 9 meters) was coated with a cohesive sealing material of Stock # PHX-3023 from Phoenix Products Company (Phoenix Products Company).

Next, using an offset printing method, a release agent is applied at a 3% solids level (obtained as a result of a deposit of about 1.1 grams per square meter) onto the cohesive sealing material , and the desired multiple A release region was prepared. The release area was rectangular (each 3 centimeters × 9 centimeters) and the release agent used was UV-9300 manufactured by GE Silicones. After the release agent was placed in place, it was exposed to ultraviolet energy to give sufficient release characteristics.

  A medical adhesive composite dressing having a size suitable for the peeling area was applied to the peeling area in a state where the pressure-sensitive adhesive was releasably adhered to the peeling area.

Next, the upper sheet of the packaging material coated with the layer of the cohesive sealing material (Stock Products PHEN-3006 from Phoenix Products Company) is attached to the lower sheet of the packaging material and the medical adhesive composite product. A package was formed. The package was then irradiated for sterilization. Thereafter, the package irradiated with radiation was opened and the product was peeled off from the peeling area, but there was no problem.

Example 6
A sample was prepared in the same manner as that used in Example 5 except that the release agent used in the release region was UV-9315 manufactured by GE Silicones. The release agent was applied using a rotogravure roller and a doctor blade, and the resulting adhesion was 1.95 grams / square meter. The formed peeling area was rectangular (2.5 centimeters × 7 centimeters). The performance of the finished packaging was satisfactory.

  Various changes and modifications of this invention will become apparent to those skilled in the art without departing from the scope and spirit of this invention. It should be understood that the invention is not unduly limited to the illustrative embodiments described herein.

Aspect 1. A packaged combination of medical adhesive composites: (a) (1) a substrate having a top surface and a bottom surface;
(2) a medical adhesive composite comprising a pressure sensitive adhesive coated on at least a part of the bottom surface of the substrate;
(B) (1) a top sheet disposed on the top surface of the substrate of the medical adhesive composite;
(2) A bottom sheet disposed under the adhesive of the medical adhesive composite, wherein the medical adhesive composite is disposed between the top sheet and the bottom sheet, and the top sheet And a bottom sheet, wherein the bottom sheet is sealed together around the medical adhesive composite;
(3) A peeling surface at least as large as the pressure-sensitive adhesive on the bottom surface of the substrate, wherein the adhesive strength between the peeling surface and the bottom sheet is such that the peeling surface and the medical use A packaged medical adhesive composite combination comprising a package containing the medical adhesive composite, including a release surface, greater than the adhesive strength between the adhesive composite and the adhesive.
2. The medical adhesive composite includes an adhesive composite dressing that is attached to at least a portion of the upper surface of the substrate, is made of a material that is substantially harder than the substrate, and has a carrier that supports the substrate. A combination product according to aspect 1.
3. The combination according to aspect 2, wherein the substrate comprises a flexible polymer film having a moisture permeation rate of not less than 300 grams / square meter at 37 ° C. and a relative humidity of 100 to 10% for 24 hours.
4). The combination according to aspect 1, 2 or 3, wherein the release surface is provided on a release liner attached to the bottom sheet.
5. The combination product according to embodiment 1, 2, or 3, wherein the release surface has a release coating on the bottom sheet.
6). A method for manufacturing a packaged medical adhesive composite combination comprising:
(A) providing a medical adhesive composite comprising a substrate having a top surface and a bottom surface, and a pressure sensitive adhesive on the bottom surface of the substrate;
(B) providing a bottom sheet of packaging material;
(C) providing a release surface between the bottom sheet of packaging material and the adhesive on the bottom surface of the substrate, the release surface being attached to the bottom sheet, the release surface A bond strength between the release sheet and the bottom sheet is greater than a bond strength between the release surface and the adhesive;
(D) providing a top sheet of packaging material on the medical adhesive composite, wherein the medical adhesive composite is disposed between the top sheet and the bottom sheet;
(E) A method for manufacturing a packaged medical adhesive composite combination comprising sealing the top sheet and the bottom sheet around the medical adhesive composite.
7). Printing on at least one of the top sheet and the bottom sheet of packaging material, the printing step sealing the top sheet and the bottom sheet of packaging material; and the top sheet and the bottom sheet The method of aspect 6, further comprising a step performed in-line with the sealing.
8). A method of using a packaged medical adhesive composite comprising:
(A) (1) (A) a substrate having an upper surface and a bottom surface;
(B) a medical adhesive composite comprising a pressure sensitive adhesive coated on at least a portion of the bottom surface of the substrate;
(2) (A) a top sheet disposed on the top surface of the substrate of the medical adhesive composite;
(B) a bottom sheet disposed under the adhesive on the bottom surface of the substrate, wherein the medical adhesive composite is disposed between the top sheet and the bottom sheet; A bottom sheet, wherein the top sheet and the bottom sheet are sealed around the medical adhesive composite;
(C) a release surface at least as large as the pressure-sensitive adhesive on the bottom surface of the substrate, the release surface being attached to the bottom sheet, and between the release surface and the bottom sheet A combination comprising a package containing the medical adhesive composite, comprising a release surface, wherein the adhesive strength is greater than the adhesive strength between the release surface and the adhesive on the bottom surface of the substrate. Providing steps;
(B) separating at least a portion of the top sheet from the bottom sheet to expose the medical adhesive composite adhered to the bottom sheet;
(C) separating the adhesive on the bottom surface of the substrate from the release surface and peeling the medical adhesive composite from the bottom sheet of the packaging material;
(D) applying the packaged medical adhesive composite comprising: applying the adhesive and attached substrate to a patient.
9. The medical adhesive composite includes an adhesive composite dressing that is attached to at least a portion of the upper surface of the substrate, is made of a material that is substantially harder than the substrate, and has a carrier that supports the substrate. A method according to aspect 6 or 8.
10. The method of embodiment 6, 8 or 9, wherein the release surface comprises a release liner attached to the bottom sheet of packaging material.
11. The method of embodiment 6, 8 or 9, wherein the release surface comprises a release coating of the bottom sheet of the packaging material.

FIG. 2 is an exploded perspective view of one dressing and package combination according to the present invention. FIG. 3 is an enlarged partial cross-sectional view of a release surface useful for some assemblies according to the present invention. FIG. 6 is a top perspective view of another dressing attached to the bottom sheet of a package of one combination according to the present invention. FIG. 3 is a bottom perspective view of the dressing of FIG. 2 after removal from the bottom sheet of the package. FIG. 6 is a top perspective view of another dressing for use in a combination according to the present invention. Fig. 4 illustrates in a flow chart steps of one method for producing a combination dressing and package according to the present invention. Fig. 4 illustrates in a flow chart steps of one method for producing a combination dressing and package according to the present invention. 1 is a schematic diagram of one method of manufacturing a dressing and package combination according to the present invention. FIG. FIG. 4 is a schematic diagram of another method of manufacturing one dressing and package combination according to the present invention. FIG. 4 is a schematic diagram of another method of manufacturing one dressing and package combination according to the present invention. FIG. 4 is a schematic diagram of another method of manufacturing one dressing and package combination according to the present invention.

Claims (6)

A packaged combination of medical adhesive composites:
(A) (1) a substrate (14) having an upper surface and a bottom surface;
(2) a medical adhesive composite (10) comprising a pressure sensitive adhesive (16) coated on at least a part of the bottom surface of the substrate (14);
(B) (1) a top sheet (20) disposed on the top surface of the substrate (14) of the medical adhesive composite (10);
(2) A bottom sheet (22) disposed under the adhesive (16) of the medical adhesive composite (10), wherein the medical adhesive composite (10) is the top sheet (20). And the bottom sheet (22), wherein the top sheet (20) and the bottom sheet (22) are sealed together around the medical adhesive composite (10). 22) and;
(3) Release surface (24) at least as large as the pressure sensitive adhesive (16) on the bottom surface of the substrate (14)
A packaged medical adhesive composite combination comprising a package containing the medical adhesive composite (10), comprising:
The top sheet (20) includes a cold aggregation sealing material layer , the bottom sheet (22) includes a cold aggregation sealing material layer (23), and the cold aggregation sealing material layer is the medical adhesive. Around the composite (10), the top sheet (20) is joined to the bottom sheet (22) so as to be sealed, and the release surface (24) is the cold cohesive seal on the bottom sheet (22). A combination product comprising a release material covering only a part of the top material layer (23). A method for manufacturing a packaged medical adhesive composite combination comprising:
(A) providing a substrate (14) having a top surface and a bottom surface, the substrate (14) comprising a pressure sensitive adhesive (16) on the bottom surface of the substrate (14);
(B) providing a bottom sheet (22) of packaging material;
(C) providing a release surface (24) between the bottom sheet (22) of packaging material and the adhesive (16) on the bottom surface of the substrate (14);
(D) providing a top sheet (20) of packaging material on the top surface of the substrate (14), wherein the medical adhesive composite (10) comprises the top sheet (20) and the bottom sheet ( 22), a step disposed between;
(E) a packaged medical adhesive composite (10) combination comprising sealing the top sheet (20) and the bottom sheet (22) around the medical adhesive composite (10); A method for manufacturing
The top sheet (20) is sealed to the bottom sheet (22) by a cold aggregation sealing material layer on the top sheet (20) and a cold aggregation sealing material layer (23) on the bottom sheet (22). And providing the release surface (24) on the bottom sheet (22) prior to placing a medical adhesive composite between the top sheet (20) and the bottom sheet (22). Coating a release material on only a portion of the cold agglomerated sealing material layer (23). A packaged combination of medical adhesive composites:
(A) (1) a substrate (14) having an upper surface and a bottom surface;
(2) a medical adhesive composite (10) comprising a pressure sensitive adhesive (16) coated on at least a part of the bottom surface of the substrate (14);
(B) (1) a top sheet (20) disposed on the top surface of the substrate (14) of the medical adhesive composite (10);
(2) A bottom sheet (22) disposed under the adhesive (16) of the medical adhesive composite (10), wherein the medical adhesive composite (10) is the top sheet (20). And the bottom sheet (22), wherein the top sheet (20) and the bottom sheet (22) are sealed together around the medical adhesive composite (10). 22) and;
(3) Release surface (24) at least as large as the pressure sensitive adhesive (16) on the bottom surface of the substrate (14)
A packaged medical adhesive composite combination comprising a package containing the medical adhesive composite (10), comprising:
The top sheet (20) includes a cold aggregation sealing material layer , the bottom sheet (22) includes a cold aggregation sealing material layer (23), and the cold aggregation sealing material layer is the medical adhesive. Around the composite (10), the top sheet (20) is joined to the bottom sheet (22) so as to be sealed, and the release surface (24) is the cold cohesive seal on the bottom sheet (22). Bonding of the release liner (24a) and the cold agglomerated sealing material layer (23) on the bottom sheet (22) includes a release liner (24a) attached to a stop material layer (23), A combination product stronger than the bond between the pressure-sensitive adhesive (16) of the medical adhesive composite (10) and the release liner (24a). The release liner (24a) is bonded to the cold aggregation sealing material layer (23) on the bottom sheet (22) by the cold aggregation sealing material layer (24c) on the release liner (24a). The combination according to claim 3. A method for manufacturing a packaged medical adhesive composite combination comprising:
(A) a substrate (14) having an upper surface and a bottom surface, a pressure sensitive adhesive (16) on the bottom surface of the substrate (14), and the pressure sensitive adhesive (16) and the substrate (14); Providing a medical adhesive composite (10) comprising a release liner (24a) coupled to the substrate;
(B) providing a bottom sheet (22) of packaging material;
(C) providing a release surface (24) between the bottom sheet (22) of packaging material and the adhesive (16) on the bottom surface of the substrate (14);
(D) providing a top sheet (20) of packaging material on the top surface of the substrate (14), wherein the medical adhesive composite (10) comprises the top sheet (20) and the bottom sheet ( 22), a step disposed between;
(E) a packaged medical adhesive composite (10) combination comprising sealing the top sheet (20) and the bottom sheet (22) around the medical adhesive composite (10); A method for manufacturing
The top sheet (20) is sealed to the bottom sheet (22) by a cold aggregation sealing material layer on the top sheet (20) and a cold aggregation sealing material layer (23) on the bottom sheet (22). And providing the release surface (24) with a release liner (24a) of a medical adhesive composite (10) on the cold cohesive sealing material layer (23) on the bottom sheet (22). The bonding between the release liner (24a) and the cold agglomerated sealing material layer (23) on the bottom sheet (22) comprises pressure-sensitive the medical adhesive composite (10) A method that is stronger than the bond between the adhesive (16) and the release liner (24a). The release liner (24a) is bonded to the cold aggregation sealing material layer (23) on the bottom sheet (22) by the cold aggregation sealing material layer (24c) on the release liner (24a). The method according to claim 5.

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